Siemens Atellica Cortisol Test Kits: Urine Results May Be Inaccurate
Siemens Healthcare recalls Atellica Cortisol 50T and 250T urine test kits due to potential inaccurate results. Affected kits have specific model numbers and lot ranges. Consumers should contact Siemens for details.
Lower-risk recall
There is a negative bias with urine patient samples and urine cortisol Quality Control (QC) results intermittently out of range low.
Contact the company
What happened, in plain English
Siemens Healthcare is recalling Atellica Cortisol 50T and 250T urine test kits because they may produce inaccurate results for cortisol levels. This could lead to incorrect health assessments if used without proper validation. Read more at govinfonow.com/recall/58751-siemens-atellica-cortisol-test-kits-urine-results-may-be-inaccurate.
Source Summary by GovInfoNow · govinfonow.com/recall/58751-siemens-atellica-cortisol-test-kits-urine-results-may-be-inaccurate · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1504-2023
Cite this page
“Siemens Atellica Cortisol Test Kits: Urine Results May Be Inaccurate.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/58751-siemens-atellica-cortisol-test-kits-urine-results-may-be-inaccurate. Based on FDA recall #Z-1504-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1504-2023%22&limit=1).
Why it’s dangerous
The test kits may show lower cortisol levels than actual in urine samples, causing false low results. This could lead to incorrect health decisions if the test is used without proper validation.
Who’s affected
People who use Atellica Cortisol urine test kits for home health monitoring. Those with medical conditions requiring precise cortisol testing are most at risk.
How to tell if you have this one
Check for model numbers: Atellica IM Cortisol 50T (Material 10995538), 250T (Material 10995537), or REF 250T (Material 11206248). Look for specific UDI-DI codes and kit lot numbers listed in the recall notice.
- Brand
Siemens Healthcare- Category
Medical device
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Ongoing- Distribution
Worldwide distribution - US Nationwide.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-1504-2023 | Atellica IM Cortisol 50T (Material Number 10995538), 250T (Material Number 10995537), and REF 250T (Material Number 11206248). In vitro diagnostic use in the quantitative determination of cortisol in human serum, plasma (EDTA and lithium heparin), and urine.; Atellica IM Cortisol (50T) UDI-DI: 00630414598659; Kit Lot Numbers: 50732343 50733343 88975345 29106347 29107347 and higher; Atellica IM Cortisol 250T UDI-DI: 00630414598642; Kit Lot Numbers: 50734343 88974345 29105347 and higher; Atellica IM Cortisol (REF) 250T UDI-DI: 00630414293608; Kit Lot Numbers: 53842343 58039343 94430345 and higher | 34,746 kits |
| Z-1505-2023 | ADVIA Centaur Cortisol 50T (Material Number 10994924), ADVIA Centaur Cortisol 250T (Material Number 10994926), and ADVIA Centaur Cortisol REF 250T (Material Number 10994927). In vitro diagnostic use in the quantitative determination of cortisol in human serum, plasma (EDTA and lithium heparin), and urine.; ADVIA Centaur Cortisol (50T) UDI-DI: 00630414602943; Kit Lot Numbers: 49741344 07241346 88318346 29109348 and higher; ADVIA Centaur Cortisol 250T UDI-DI: 00630414602950; Kit Lot Numbers: 49742344 88319346 29108348 and higher; ADVIA Centaur Cortisol (REF) 250T UDI-DI: 00630414598659; Kit Lot Numbers: 75474344 11352346 and higher | 18,961 kits |
What to do — step by step
Check Kit Details
Review the UDI-DI code and kit lot numbers on your test kit to confirm if it's affected.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “Worldwide distribution - US Nationwide.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 55 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-1504-2023 (March 16, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1504-2023 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.